Replies to post #1217 on Ardelyx Inc (ARDX)

[Whalatane]

Thx for the detail . I think this drug eventually gets approved for dialysis patients.
The challenge is going to be in how to transition the dialysis patients onto it .....thru the initial risk of diarrhea phase. .
Remember that these patients are hooked up to a machine 3-4 hrs a day , usually 3 times a week.
They dont stop the machines for bath room breaks.
Patients hate the current phosphate binders so if they can overcome / work thru the risk of diarrhea phase...Nephrologists and patients will want the drug .

Anything U pick up on that ( handling the transition ) , please post.
Kiwi

[Whalatane]

Well they definitely want XPHOZAH approved in some form by Nov 30th 2023

In February, the company reported that it had amended the debt financing agreement with SLR Investment Corp. it entered into in February 2022.
The senior term loan facility’s March 1, 2027 maturity date is unchanged; however, the interest only period for the $27.5 million that was drawn at the February 2022 closing may be extended by one year to March 31, 2025 if certain product revenue targets are achieved for the year ended 2023 or the company has received approval by the FDA for the NDA for XPHOZAH on or before November 30, 2023.
In addition, the deadline to borrow an additional $22.5 million available under the facility has been extended to December 20, 2023, provided that the company has received approval by the FDA for the NDA for XPHOZAH on or before November 30, 2023 and that the company has achieved certain product revenue targets.

Six months is standard review for an NDA and 2 mths for accelerated review ?
They had a nett loss of $67m in 2022 and currently have about $120m cash on hand

Kiwi